Integra cranial access kit recalled for sterile packaging failure
Integra LifeSciences is recalling 1,324 cranial access kits due to sterile packaging defects that may compromise product sterility.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Class II recall for packaging integrity failure resulting in potential sterility compromise. No illnesses or injuries reported; the hazard is preventive rather than confirmed.
Plain-English summary
Integra LifeSciences Corp. is recalling 1,324 units of the Integra Cranial Access Kit (Ref No: INS5HND) worldwide due to a defect in the sterile packaging of the product.
The header bag packaging failed required integrity testing criteria, which means the sterility of the device may be compromised. These kits are designed for neurosurgical access to the subarachnoid space or lateral ventricles of the brain.
The affected products have been distributed in the United States and 17 other countries including Canada, France, Germany, Spain, United Kingdom, and others. Affected lot numbers include 7249001, 7253133, 7253134, 7253135, 7253136, 7275711, and 7300837, with expiration dates ranging from June 29, 2025 to July 29, 2025.
Healthcare facilities should stop using affected units and contact Integra LifeSciences for return or replacement instructions.
The recalled product
- Product
- Ref No: INS5HND / Integra Cranial access kit (without Prep solutions) Bit and Guard. For access to the subarachnoid space or the lateral ventricles of the brain.
- Manufacturer
- Integra LifeSciences Corp.
- Category
- Medical Device — Neurosurgical
- Hazard
- packaging-defect
- sterility-compromise
- infection-risk
Distribution
Distributed nationwide across the United States.
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